MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for 5500 SERIES SET SCREW 77635-45 manufactured by Corelink Llc.
[137418740]
It was discovered that a set screw had "popped out" after the patient reported hearing a squeaking noise. A revision surgery was performed to remove the hardware, and all parts were recovered and sent to corelink for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006494201-2019-00001 |
| MDR Report Key | 8336781 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-11-05 |
| Date Added to Maude | 2019-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ALLISON SCHMIDT |
| Manufacturer Street | 2072 FENTON LOGISTICS PARK |
| Manufacturer City | FENTON MO 63026 |
| Manufacturer Country | US |
| Manufacturer Postal | 63026 |
| Manufacturer Phone | 8883497808 |
| Manufacturer G1 | CORELINK SURGICAL LLC |
| Manufacturer Street | 2072 FENTON LOGISTICS PARK |
| Manufacturer City | FENTON MO 63026 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63026 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 5500 SERIES SET SCREW |
| Generic Name | SET SCREW |
| Product Code | MCV |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2018-12-18 |
| Model Number | 77635-45 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORELINK LLC |
| Manufacturer Address | 2072 FENTON LOGISTICS PARK FENTON MO 62026 US 62026 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-13 |